APEAZ ULTRA (camphor- synthetic, menthol, and methyl salicylate cream cream

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

MAH:

Innovus Pharmaceuticals, Inc.

administration_route:

Topical

prescription_type:

OTC DRUG

therapeutic_indication:

Topical analgesic For the temporary relief of minor aches and pains of muscles and joints associated with: - simple backache - arthritis - strains - bruises - sprains - on wounds or damaged, broken or irritated skin - with a heating pad - condition worsens or symptoms persist for more than 7 days - symptoms clear up and occur again within a few days - excessive skin irritation occurs

authorization_status:

OTC monograph not final

SPC

APEAZ ULTRA- CAMPHOR (SYNTHETIC), MENTHOL, AND METHYL SALICYLATE
CREAM CREAM
INNOVUS PHARMACEUTICALS, INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
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APEAZ ULTRA
_ACTIVE INGREDIENT_
Camphor 4%
Menthol 7.5%
Methyl Salicylate 10%
PURPOSE
Topical analgesic
USES
For the temporary relief of minor aches and pains of muscles and
joints associated with:
simple backache
arthritis
strains
bruises
sprains
WARNINGS​
For external use only.
DO NOT USE
on wounds or damaged, broken or irritated skin
with a heating pad
WHEN USING THIS PRODUCT
avoid contact with eyes or mucous membranes
do not bandage tightly
STOP USE AND ASK A DOCTOR
condition worsens or symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
excessive skin irritation occurs
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Center immediately
DIRECTIONS
use only as directed
adults and children 12 years of age and older: apply to affected area
not more than 3
to 4 times daily
children under 12 years of age: ask a doctor
OTHER INFORMATION
Store at 20° to 25°C (68° to 77°F)
Do not purchase if outer seal is broken
INACTIVE INGREDIENTS
carbomer, cetearyl alcohol, water, FD&C Blue no 1, FD&C Yellow no 5,
glucosamine
sulfate, glyceryl monostearate, methyl sulfonyl methane,
methylparaben, mineral oil 90,
PEG-100, propylparaben, polysorbate 60, stearyl alcohol,
triethanolamine
APEAZ ULTRA
camphor (synthetic), menthol, and methyl salicylate cream cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:57483-101
ROUTE OF ADMINISTRATION
Topical
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) -
UNII:5TJD82A1ET)
CAMPHOR
(SYNTHETIC)
4.0 mg
in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
MENTHOL
7.5 mg
in 1 g
METHY